Registration for Fall 2026 programs and courses is now open. Learn more about the academic programs we are delivering in Fall 2026. If you have any questions about part-time studies, please contact us.
Corequisites:
PFT930 - Industrial Drug Legislation
This course describes the role of the Regulatory Affairs department in a pharmaceutical firm and focuses on the "submission process" - the regulatory requirements at the various stages in a drug product's development from inception through IND (Investigational New Drug) and NDS (Notice Of Compliance). The functions of relevant divisions of the Health Protection Branch are discussed. Also covered are: DINs (Drug Identification Numbers), Provincial Formulatory Submissions, drug labelling and drug advertising, SOPs (Standard Operating Procedures), compliant handling (including Adverse Drug Reactions), recalls, Plant Master Files (PMF), Drug Master Files (DMF) and regulatory inspections. (Lecture only)
Ancillary fees will be added at checkout and will vary based on the number of courses selected. For details on how the fees are calculated, please refer to ancillary fees for part-time studies.